MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number 3GTQ3-CG

Device Problems Sticking (1597); Difficult or Delayed Activation (2577); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) - should additional information become available, a supplemental record will be filed.

Event Description

The provider states the joystick is allegedly sticking.The provider states the end user will be going forward then pull back on the joystick and alleged there was a delay.He states the end user alleged he broke his toe and ankle.He states the end user complained of the sticking joystick on (b)(6) 2015 which was when he was informed of the injury.The provider wasn't with the joystick or chair to obtain specifics on the injury and medical intervention but states the end user states he needs surgery.The dealer called back and states the errors he seen in the fault log was e18 and it is in the fault log eight times.The dealer also stated that left front caster is floating but making noise.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: custom power wheelchairs, controller/joystick/options, hold for detailed evaluation.Missing joystick knob and skirt.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint of the inductive sticking was not confirmed.Likewise the complaint of a delay when changing directions was not confirmed.The inductive functioned properly, including giving an e18 error code when the joystick was powered up with the inductive out of neutral but not driving.A loose washer in the inductive boot was found that could have impeded the motion of the inductive rod if wedged between the rod and the hole in the joystick case.However, such a failure could not be reproduced during testing.Complaint of joystick is sticking, going forward then pull back on the joystick and there was a delay was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: custom power wheelchairs, controller/joystick/options, hold for detailed evaluation.Missing joystick knob and skirt.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint of the inductive sticking was not confirmed.Likewise the complaint of a delay when changing directions was not confirmed.The inductive functioned properly, including giving an e18 error code when the joystick was powered up with the inductive out of neutral but not driving.A loose washer in the inductive boot was found that could have impeded the motion of the inductive rod if wedged between the rod and the hole in the joystick case.However, such a failure could not be reproduced during testing.The provider states the joystick is allegedly sticking.The provider states the end user will be going forward then pull back on the joystick and alleged there was a delay.He states the end user alleged he broke his toe and ankle.He states the end user complained of the sticking joystick on 7/23/15 which was when he was informed of the injury.The provider wasn't with the joystick or chair to obtain specifics on the injury and medical intervention but states the end user states he needs surgery.The dealer called back and states the errors he seen in the fault log was e18 and it is in the fault log eight times.The dealer also stated that left front caster is floating but making noise.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4989935
• MDR Text Key: 22490458
• Report Number: 1525712-2015-04097
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3GTQ3-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention